Medication Abortion in Early Pregnancy

1. Medication Abortion in Early Pregnancy Induced termination of early intrauterine pregnancy using medications

2. Please complete this pre-test on your phone in order to get CME for your participation in this workshop. You can access the pre-test at: https://www.surveymonkey.com/r/MedAbPre CE Pre-Test

3. Describe disparities in unintended pregnancy rates in the US. • Explain the tenets of non-judgmental options counseling. • Access resources to integrate medication abortion into primary care practice. Objectives

4. 6.1 million pregnancies/year in the U.S. Guttmacher Institute, 2018 (2011 data)

5. Unintended pregnancy rate by race, ethnicity, and income Finer and Zolna, 2016 (2011 data)

6. Outcomes of unintended pregnancies (Approximately 2.8 million annually) Guttmacher, 2018 (2014 data)

7. 88% of abortions occur in the first 12 weeks of pregnancy Guttmacher Institute, 2019

8. Physicians • Advanced Practitioner Clinicians (nurse practitioners, certified nurse midwives, physicians assistants) • In some countries, registered nurses (RNs) provide medication abortion, however, not in the US. Who provides abortions?

9. Abortion access Guttmacher Institute, 2017 (2014 data)

10. Medication & aspiration abortion: both safe and effective

11. Safety of abortion • First trimester abortions do not increase risk of: • Infertility • Ectopic pregnancy • Miscarriage • Birth defect • Preterm or low-birthweight delivery National Academies of Sciences, Engineering, and Medicine. 2018

12. Medication abortion regimens: three choices Mifepristone + Misoprostol Misoprostol alone Methotrexate + Misoprostol

13. Mifepristone + Misoprostol The most common regimen in the U.S.

14. Medication abortion: advantages • 98-99% effective • Avoids surgical and anesthetic risk • Greater patient autonomy and privacy • Less invasive • More “natural”

15. Aspiration abortion: advantages • Slightly more effective (99%) • Shorter time to completion • Shorter bleeding duration • Can be performed later in gestation

16. Misoprostol Route and Timing

17. Mifepristone Misoprostol Causes progesterone blockade Causes uterine cramping and expulsion Decidual necrosis Cervical ripening Detachment

18. 22 years old • Requests a pregnancy test Yolanda

19. Review all options • Ensure the decision is hers Yolanda – counseling issues

20. Establish gestational age • Rule out contraindications: • Allergy to meds • Chronic adrenal failure • Long-term systemic corticosteroid therapy • Anti-coagulant use (excluding aspirin) • IUD in place • No access to follow-up • Ectopic pregnancy • Indications for sonography Next steps

21. Gestational age: 6 weeks • Patient agreement Yolanda

22. What happens next? Yolanda takes mifepristone in your office, or later at home At home, Yolanda takes pain meds, then misoprostol

23. Follow Up: In office or by phone • 7-14 days later • Assure completion • Process experience • Review contraceptive choice

24. Phone calls after medication abortion “There wasn’t much blood.” “Am I still pregnant?” Was there some bleeding? Any cramping? Did you take the misoprostol? Ask if pregnancy symptoms have disappeared. “I’m bleeding and cramping a lot.” “I’m still bleeding after 2 weeks.” That’s normal unless you’re soaking two heavy pads an hour for two consecutive hours. Offer follow-up appointment. That’s normal unless you’re soaking two heavy pads an hour for two consecutive hours.

25. Clostridium sordellii • 6 deaths in North America due to toxic shock with Clostridium following medication abortion • Similar deaths, however, also seen following miscarriage, childbirth, trauma, & surgery • CDC: no causal link between medications and these incidents Source: CDC 2006, FDA 2006

26. Methotrexate and misoprostol medication abortion

27. 800 mcg vaginally • More than one dose might be needed Misoprostol alone medication abortion

28. What barriers do you anticipate if you were to try to provide medication abortions in your office?

29. Laws regulating abortion in your state Staff support Pharmacy Clinical policies + procedures Charting Billing & reimbursement Professional liability insurance Issues to think about

30. Conclusion From pregnancy diagnosis through week eleven, medication abortion is safe and effective. As its success depends on accessibility and counseling, medication abortion is well suited to primary care settings.

31. References Baird D. Mode of action of medical methods of abortion. JAMWA. 2000; 35(3): S121-126. Beverly W, Dzuba IG, Chong E, et al. Extending Outpatient Medical Abortion Services Through 70 Days of Gestational Age. Obstetrics & Gynecology. 2012;120(5):1070-1076. doi:10.1097/AOG.0b013e31826c315f. Blanchard K, Shochet T, Coyaji K, ThiNhu Ngoc N, Winikoff B. Misoprostol alone for early abortion: an evaluation of seven potential regimens. Contraception. Aug 2005;72(2):91-97. Blanchard K, Winikoff B, Ellertson C. Misoprostol used alone for the termination of early pregnancy. A review of the evidence. Contraception. Apr 1999;59(4):209-217. Bracken, H., N.T.N. Ngoc, E. Schaff, K. Coyaji, S. Ambardekar, E. Westheimer, B. Winikoff. Mifepristone Followed in 24 Hours to 48 Hours by Misoprostol for Late First-Trimester Abortion. Obstetrics and Gynecology (Apr 2007), 109 pp.895-901. Coyaji,K., U. Krishna, S. Ambardekar, H. Bracken, V. Raote, A. Mandlekar, B. Winikoff. Are two doses of misoprostol after mifepristone for early abortion better than one? British Journal of Obstetrics and Gynaecology, (Mar 2007), 114 (3), pp. 271–278. Creinin MD, Fox MC, Teal S, Chen A, Schaff EA, Meyn LA: MOD Study Trial Group: A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Obstet. Gynecol. 2004 103(5 Pt. 1): 851-859. Finer LB and Zolna MR, Declines in Unintended Pregnancy in the United States, 2008–2011; The New England Journal of Medicine 2016, 374(9):843-52. Finer LB and Zolna MR, Shifts in intended and unintended pregnancies in the United States, 2001–2008, American Journal of Public Health, 2014, 104(S1):S44–S48 Frost JJ, Frohwirth LF, Zolna MR. Contraceptive Needs and Services, 2014 Update. Guttmacher Institute, September 2016. https://www.guttmacher.org/report/contraceptive-needs-and-services-2014-update. Guest J, Chien P, Thomson M, Kosseim ML. Randomised controlled trial comparing efficacy of same day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36- to 48-hour protocol. Bjog. Oct 2005;112(10):1457. Guttmacher Institute. Abortion Access in the United States, 2014, https://www.guttmacher.org/infographic/2017/abortion-access-united-states-2014.

32. References Guttmacher Institute. Abortion Incidence and Service Availability in the United States, 2014, https://www.guttmacher.org/journals/psrh/2017/01/abortion-incidence-and-service-availability-united-states-2014. Guttmacher Institute. Fact Sheet: Induced Abortion in the United States, 2018. https://www.guttmacher.org/sites/default/files/factsheet/fb_induced_abortion.pdf. Herrmann WL et al. Effects of the antiprogesterone RU 486 in early pregnancy and during the menstrual cycle. Future aspects in contraception. 1984 Ch. 22:249-70. Ho PC, Blumenthal PD, Gemzell-Danielsson K, Gómez Ponce de León R, Mittal S, Tang OS. Misoprostol for the termination of pregnancy with a live fetus at 13 to 26 weeks. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S178-81. Jain JK, Dutton C, Harwood B, Meckstroth KR, Mishell DR, Jr. A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Hum Reprod. Jun 2002;17(6):1477-1482. Li C-L, Chen D-J, Song L-P, et al. Effectiveness and Safety of Lower Doses of Mifepristone Combined With Misoprostol of the Termination of Ultra-Early Pregnancy: A Dose-Ranging Randomized Controlled Trial. Reproductive Sciences. 2014;22(6):706-711. Moreno-Ruiz NL, Borgatta L, Yanow S, Kapp N, Wiebe ER, Winikoff B. Alternatives to mifepristone for early medical abortion. Int J Gynaecol Obstet. 2007 Mar;96(3):212-8. National Academies of Sciences, Engineering, and Medicine. 2018. The Safety and Quality of Abortion Care in the United States. Washington, DC: The National Academies Press. https://doi.org/10.17226/24950. Schaff EA, Eisinger SH, Stadalius LS, Franks P, Gore BZ, Poppema S. Low-dose mifepristone 200 mg and vaginal misoprostol for abortion. Contraception. Jan 1999;59(1):1-6. Schaff EA, et al. Vaginal misoprostol administered at home after mifepristone (RU486) for abortion. J Fam Pract 1997;44:353-60. Schaff EA, Fielding SL, Eisinger SH, Stadalius LS, Fuller L. Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days. Contraception. Jan 2000;61(1):41-46.

33. References Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. Aug 2001;64(2):81-85. Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol 2 days after mifepristone 200 mg for abortion up to 63 days of pregnancy. Contraception. Oct 2002;66(4):247-250. Schaff EA, Fielding SL, Westhoff C, et al. Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: A randomized trial. Jama. Oct 18 2000;284(15):1948-1953. Shannon C., E. Wiebe, F. Jacot, E. Guilbert, S. Dunn, W.R. Sheldon, B. Winikoff. Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial. British Journal of Obstetrics and Gynaecology (Jun 2006), 113(6), pp 62-628. Singh S, Sedgh G and Hussain R, Unintended pregnancy: worldwide levels, trends and outcomes, Studies in Family Planning, 2010, 41(4):241–250. Swahn ML, Cekan S, Wang G, Lujndstrom V, Bygdeman M. Pharmacokinetic and clinical studies of RU 486 for fertility regulation. In: Beaulieu EE, Siegel S, eds. The Antiprogestin Steroid RU 486 and Human Fertility Control. New York, NY: Plenum; 1985:249-258. van Bogaert LJ, Sedibe TM. Efficacy of a single misoprostol regimen in the first and second trimester termination of pregnancy. J ObstetGynaecol. 2007 Jul;27(5):510-2. Weeks AD and Stewart P. The use of low dose mifepristone and vaginal misoprostol for first trimester termination of pregnancy. Br J Fam Planning 1995;21:85-86. Wiebe ER, Trouton KJ, Lima R. Misoprostol alone vs. methotrexate followed by misoprostol for early abortion. Int J Gynaecol Obstet. 2006 Dec;95(3):286-7. Winikoff B. Oral vs buccal administration of misoprostol after mifepristone for medication abortion up to 63 days. Obstetrics and Gynecology 2008, accepted for publication. World Health Organization Task Force on Post-Ovulatory Methods of Fertility Regulation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomized trial. BJOG2000 107(4): 524-530.